CN102224400B - Packaging material for a pharmaceutical product - Google Patents

Abstract

The invention discloses a packaging material for medical products. The packaging material included colored cells that partially faded at about 38°C to reveal the indicia. The colored element is formed from a first part forming a mark printed with conventional ink and a second part printed with thermochromic ink. Thermochromic inks are colored below about 38°C and become colorless when this temperature is reached or exceeded. The two parts are arranged such that the first part is not visible below about 38°C, but becomes visible when that temperature is reached or exceeded.

Description

Packaging materials for pharmaceutical products

technical field

The invention relates to a packaging material for pharmaceutical products and also to a production method for such a packaging material.

Background technique

There are known medicinal products capable of reducing fever. The name of said medicinal product is also known as antipyretic. Typical antipyretics are paracetamol, aspirin, flumonic acid, nimesulide, ketoprofen, flurbiprofen and some of their derivatives.

It is also known to exist substances that are capable of changing color at a predetermined temperature. Such substances are said to be "thermochromic". In general, the substances form part of liquid crystals.

In the last few decades, various inks based on thermochromic substances have been developed. These inks are known as "thermochromic inks" and are used in screen printing, flexographic printing, wet offset printing, lithograph printing and the like.

Some of these inks are colored and change color at a predetermined temperature. Other thermochromic inks are colorless and become colored at a predetermined temperature. There are still other inks which are colored but become colorless at a predetermined temperature.

US 2006/0241355 discloses a healthcare base comprising an area for receiving a bottle carrying a healthcare-related substance to be taken by the user. The bottle can be provided with a thermometer obtained with thermochromic pigments. The temperature sensor consists of a series of points arranged in a column with two axes. One axis is at intervals of one degree and the other at intervals of 0.2 degrees. To use the thermometer, the user holds the bottle and presses it to his/her forehead for a period of time. The user then lifts the bottle from the forehead to read the temperature.

Contents of the invention

The inventors have noted that the bottle with thermometer disclosed in US 2006/0241355 is neither comfortable nor discrete to use. In practice, to measure temperature, the patient/user should hold the thermometer (ie bottle) against the skin surface so that each point on the column touches the patient's body (eg forehead). However, holding a bottle and pressing it against one's forehead is an attractive gesture that the patient/user may prefer not to do in certain situations (eg while traveling, in the office, etc.).

The inventors realized that if s/he has a fever and thus if s/he needs to take medication, even without an accurate measurement of her/his temperature, the packaging of the antipyretic is equipped with the Or denoted units would also be useful. This is especially useful when the patient/user does not have a thermometer in their environment. In fact, the patient/user can first use the pack to verify that s/he has a fever and then (eg when s/he comes home) use the thermometer to measure his/her temperature.

In addition, the inventors have noticed that the technology of thermochromic inks has not been widely adopted so far because it has many disadvantages caused by varying gravity depending on the characteristics of the thermochromic ink used.

In particular, the inventors realized that these thermochromic inks, which are colored below their transition temperature but become colorless when said temperature is reached or exceeded, are very disadvantageous. In fact, the markings printed with said ink disappear when the transition temperature is reached and this fact does not allow to send clear and precise information or messages to the patient/user as to whether said temperature is reached or not.

Accordingly, the inventors have solved the problem of providing a packaging material for medicinal products that overcomes the above-mentioned disadvantages.

In particular, the inventors have solved the problem of providing a packaging material for medicinal products, and using a sign capable of sending a clear message to the patient/user as to whether a temperature has been reached, in contrast to the above known solutions The packaging material can indicate to the patient/user whether or not she/he has a fever in a simpler and more discrete manner than with conventional protocols.

In the course of the present description and in the claims the wording:

- "Packaging material" is used to mean any container, any sign, any label or any paper present in the packaging of a medicinal product. The expression "packaging material" is also used herein to denote any other type of material that coexists with a medicinal product that is distributed, given and/or sold by the manufacturing establishment. Typical containers according to the invention are cases, boxes, vials, vials, blister packs, sachets and the like.

- "Sign" is used to mean any design, shape, letter of the alphabet, word, number, symbol, logotype and any combination thereof. Typically, the sign represents an information, a warning, a message or an alarm condition to the operator and/or patient/user;

- "Visible" is used to mean that the markings are clearly discernible by the human eye when viewed by an ordinary attentive person. On the other hand, the term "invisible" is used to mean that the markings cannot be clearly discerned by the human eye when viewed by a person with ordinary attention;

- "approximately 38°C" means a temperature of 38°C ± 0.5°C; and

- "conventional ink" is used to denote an ink which, in the temperature range between 30°C and 45°C, does not undergo a color change visible to the human eye when observed by an ordinary minded person and which Ink does not change from colorless to colored or vice versa.

According to its first aspect, the present invention relates to a packaging material for medicinal products having a colouredelement which partially fades at about 38°C to reveal indicia, wherein:

(a) said cell is formed from a first part forming said indicium printed with conventional ink and a second part printed with thermochromic ink;

(b) said thermochromic ink is colored below about 38°C and becomes colorless when said temperature is reached or exceeded; and

(c) the first and second portions are arranged such that the first portion is not visible below about 38°C, but becomes visible when the temperature is reached or exceeded.

The above wording "partially discolored" with respect to the above colored elements is intended to mean that only the first part, but not the second part, is discolored.

Preferably, said thermochromic ink is of the reversible type, ie it returns to a colored state when the temperature falls below about 38°C.

In a first preferred embodiment of the packaging material according to the invention, said second part is superimposed on the first part.

In a second preferred embodiment of the packaging material according to the invention, said first and second portions of said colored elements are arranged juxtaposed to each other.

Preferably, when the first part has a space without conventional ink, the second part of the colored element also covers said space.

Preferably, in this second embodiment, the color of the thermochromic ink is quite similar to that of a conventional ink below about 38°C.

Even more preferably, the color of the thermochromic ink is as similar as possible to the color of a conventional ink below about 38°C.

Preferably, said medicinal product is an antipyretic.

According to its second aspect, the present invention relates to a method for the production of packaging material for medicinal products having colored elements partially discolored at about 38° C. to reveal indicia, the production of said colored elements comprising the following steps:

a) obtain packaging materials;

b) the indicia are printed thereon using conventional types of ink;

c) Applying a thermochromic ink that is colored below a temperature of about 38°C but becomes colorless when that temperature is reached such that the indicia Essentially invisible when the temperature is reached, but becomes visible when the temperature is reached or exceeded.

The thermochromic ink is preferably of the reversible type, ie it returns to a colored state when the temperature falls below about 38°C.

In a first preferred embodiment of the method according to the invention, said thermochromic ink forms a layer superimposed on the marking.

In a second preferred embodiment of the method according to the invention, said thermochromic ink is applied so as to form a layer next to said marking.

Preferably, when the indicium has voids without conventional ink, said voids are also covered with a layer of thermochromic ink.

Preferably, in this second embodiment, below about 38°C, the color of the thermochromic ink is completely similar to the color of conventional inks used for already printed indicia.

Even more preferably, below about 38°C, the color of the thermochromic ink is as similar as possible to the color of conventional inks with which indicia have been printed.

Description of drawings

The invention will now be further illustrated with reference to the accompanying drawings provided by way of non-limiting example, in which:

Figure 1 is a schematic perspective view of a packaging material according to a first preferred embodiment of the present invention, wherein the temperature of the colored unit is lower than about 38°C;

Fig. 2 is a schematic diagram of the material according to Fig. 1, wherein a patient/user with a fever presses his thumb on the colored element;

Figure 3 is a schematic view of the material according to Figure 1 immediately after the patient/user has removed his thumb from the colored unit;

Figure 4 is a schematic perspective view of a packaging material according to a second preferred embodiment of the present invention, wherein the temperature of the colored unit is lower than about 38°C;

Fig. 5 is a schematic diagram of the material according to Fig. 4, wherein the temperature of the colored unit is equal to or higher than about 38°C.

Detailed ways

Figures 1-3 show a packaging material 1 according to a first preferred embodiment of the invention. The packaging material 1 is a parallelepiped-shaped box containing a medicinal product. Preferably, said medicinal product is a medicine that is useful or must be taken during a fever. More preferably, said medicinal product is an antipyretic.

As already stated, this type of packaging material is non-limiting, as the packaging material can be logos, labels, vials, sachets, blister packs, vials, boxes, powder sachets or any other packaging materials. The packaging material 1 may also be any other type of material that coexists with the medicinal product distributed, presented and/or sold by the manufacturing enterprise.

According to a preferred embodiment of the invention, the colored unit 2 is associated with the packaging material 1 .

This colored unit 2 is advantageously arranged on the outer surface of the opening/closing flap 3 of the box 1 so that it is easy for the patient/user with a fever to hold the colored unit 2, the patient/user having to apply a certain pressure on it with his thumb on colored cells (Fig. 2).

Preferably, the colored unit 2 comprises a conventional red ink and a thermochromic ink that changes from a red to a colorless state at about 38°C. Preferably, the color change of the thermochromic ink is reversible in that its color changes to red again when the temperature falls below said temperature.

More specifically, said conventional ink preferably forms a mark 2' consisting of a graphic of a distressed face, and said thermochromic ink forms a layer 2" superimposed on the mark 2'.

When the temperature of the cell 2 is below about 38°C, the layer 2" of thermochromic ink completely covers the marking 2' and renders the marking 2' invisible (Fig. 1).

However, when the temperature of the cell 2 is equal to or higher than 38°C, the layer 2" of thermochromic ink preferably becomes colorless and makes the marking 2' visible (Fig. 3).

Thus, the appearance of the sign 2' tells the patient/user that he has a fever and that he needs to take the antipyretic medicine contained in the box 1 .

Alternatively, the sign 2' may be formed by any other figure, symbol or word capable of informing the patient/user that his body temperature is about 38°C, instead of being formed by the figure of a sick face. For example, the notation 2' could simply consist of the symbol "38°C".

Figures 4 and 5 show a packaging material 11 according to a second preferred embodiment of the invention.

The packaging material 11 is different from the packaging material in FIGS. 1-3, firstly, the thermochromic ink forms a layer 12 ", the layer 12 " surrounds the mark 12' and is juxtaposed with the mark 12', and fills the blank space without traditional ink ( ie eyes and mouth), thereby forming a colored unit 12 in which the marking 12' is invisible as long as the temperature of the packaging material 1 is below said predetermined temperature (Fig. 4).

In the embodiment of FIG. 4 a thermochromic ink is used, the color of which is substantially equal to the color of the conventional ink below about 38° C. with which the indicia 12 ′ has been printed so that the indicia 12 ' became essentially invisible.

Finally, Figure 5 shows the indicia 12' that appear after the thumb of the febrile patient has pressed the unit 12.

Examples of suitable thermochromic inks according to preferred embodiments of the present invention are those inks described in US 4,385,844.

Another suitable thermochromic ink according to a preferred embodiment of the present invention is the offset printing ink DYNACOLOR ^™ manufactured by CTI (Chromatic Technologies Incorporated), Colorado Springs, Colorado, USA. Patents US 5,591,255 and US 5,997,849 describe such inks.

Other suitable thermochromic inks according to preferred embodiments of the present invention are inks produced by SICPA SA of Praly, Switzerland.

According to a preferred embodiment of the present invention, the printing technique is screen printing and flexography.

Although the packaging material of the preferred embodiments of the invention has been further illustrated above with particular reference to packaging for antipyretics, it is clear that the invention can also be advantageously associated with any other medicinal product that needs to be taken during a fever ground use.

Claims (15)

1. A packaging material (1, 11) for pharmaceutical products having a colored unit (2, 12) which partially fades at about 38°C to reveal indicia (2', 12'), wherein : (a) said unit (2, 12) is formed by a first part forming said marking (2', 12') printed with conventional ink, and a second part (2", 12"), said The second part is printed with thermochromic ink; (b) the thermochromic ink is colored below about 38°C and becomes colorless at or above that temperature; and (c) said first part (2', 12') and second part (2", 12") are arranged such that said first part (2', 12') is invisible below about 38°C, but become visible when the temperature is reached or exceeded; and (d) Said packaging material ( 1 , 11 ) is the paper or box ( 1 ) present in the packaging of medicinal products. 2. Packaging material (1, 11) according to claim 1, wherein said thermochromic ink is of reversible type. 3. Packaging material (1 ) according to claim 1 or 2, wherein the second part (2") is superimposed on the first part (2'). 4. The packaging material (11) according to claim 1 or 2, wherein the first part (12') and the second part (12") of the colored elements (12) are arranged juxtaposed to each other. 5. Packaging material (11) according to claim 4, wherein said second part (12) of said colored unit (12) is ") also cover said white space. 6. The packaging material (11) according to any one of claims 1 and 2, wherein below about 38°C the color of the thermochromic ink is completely similar to the color of the conventional ink. 7. The packaging material (11) according to any one of claims 1 and 2 above, wherein below about 38°C the color of the thermochromic ink is as similar as possible to the color of the conventional ink. 8. The packaging material (11) according to claim 1, wherein the medicinal product is an antipyretic. 9. A method for the production of a packaging material (1, 11) for pharmaceutical products having colored elements (2, 12) which partially fade at about 38°C to reveal markings (2', 12 '), the production of the colored unit (2, 12) includes the following steps: a) obtaining packaging materials (1, 11); b) printing said markings (2', 12') thereon using conventional type of ink; c) Applying a thermochromic ink that is colored below a temperature of about 38°C but becomes colorless when that temperature is reached such that the marks (2', 12' ) are substantially invisible below said temperature, but become visible at or above said temperature, Wherein said packaging material (1, 11) is the paper or box (1) present in the packaging of pharmaceutical products. 10. The method of claim 9, wherein the thermochromic ink is of the reversible type. 11. Method according to claim 9 or 10, wherein said thermochromic ink forms a layer (2") superimposed on said marking (2'). 12. A method according to claim 9 or 10, wherein the thermochromic ink is applied so as to form a layer (12") juxtaposed to the indicia (12'). 13. The method according to claim 12, wherein when the marking (12') has a blank space without conventional ink, the layer (12") of the thermochromic ink also covers the blank space. 14. A method according to any one of claims 9 and 10, wherein below about 38°C the color of said thermochromic ink is completely similar to said conventional ink with which said indicia (12') has been printed The color of the ink. 15. A method according to any one of claims 9 and 10, wherein below about 38°C the color of said thermochromic ink is as similar as possible to said ink with which said indicia (12') has been printed. The color of traditional ink.

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